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FDA 510(k)

Dexter L6 System

K-Number: K250435 · 2025-05-27

ApplicantDistalmotion SA
Decision Date2025-05-27
Product CodeSDD
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Dexter L6 System is a medical device manufactured by Distalmotion SA. It received FDA 510(k) clearance on 2025-05-27 under approval number K250435. The device is classified under product code SDD. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Dexter L6 System?

Dexter L6 System is a medical device that received FDA 510(k) clearance on 2025-05-27. It is manufactured by Distalmotion SA. The 510(k) number is K250435.

When was Dexter L6 System approved by the FDA?

Dexter L6 System received FDA 510(k) clearance on 2025-05-27, under approval number K250435.

What company makes Dexter L6 System?

Dexter L6 System is manufactured by Distalmotion SA.

What is the FDA product code for Dexter L6 System?

The FDA product code for Dexter L6 System is SDD.

Related Clinical Trials

NCT07031050 Robotic Sacrocolpopexy and Sacrocervicopexy - an Observational Study to Confirm the Peri- and Postoperative Safety and Clinical Performance COMPLETED NCT07123051 Robotic Assisted Right Colectomy With the DEXTER Robotic Surgery System RECRUITING

Other Devices by Distalmotion SA

DEN230084Dexter L6 System K251197Dexter L6 System

Related Devices (Code: SDD)

DEN230084Dexter L6 SystemDistalmotion SA K251197Dexter L6 SystemDistalmotion SA

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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